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Amphastar Pharmaceuticals(AMPH) - 2023 Q4 - Annual Results
2024-02-27 16:00
[Financial Highlights](index=1&type=section&id=Financial%20Highlights) [Fourth Quarter Highlights](index=1&type=section&id=Fourth%20Quarter%20Highlights) In the fourth quarter of 2023, Amphastar reported net revenues of **$178.1 million**, a **32%** increase year-over-year, with GAAP net income of **$36.2 million** (**$0.68** per diluted share) and adjusted non-GAAP net income of **$46.9 million** (**$0.88** per diluted share) Q4 2023 Key Financial Metrics | Metric | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | | Net Revenues | $178.1 million | $135.0 million | | GAAP Net Income | $36.2 million | $33.9 million | | GAAP Diluted EPS | $0.68 | $0.66 | | Adjusted non-GAAP Net Income | $46.9 million | $37.6 million | | Adjusted non-GAAP Diluted EPS | $0.88 | $0.73 | [Full-Year Highlights](index=1&type=section&id=Full-Year%20Highlights) For the full fiscal year 2023, the company achieved net revenues of **$644.4 million**, up **29%** from 2022, with GAAP net income of **$137.5 million** (**$2.60** per share) and adjusted non-GAAP net income of **$175.7 million** (**$3.32** per share) Full-Year 2023 Key Financial Metrics | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Net Revenues | $644.4 million | $499.0 million | | GAAP Net Income | $137.5 million | $91.4 million | | GAAP Diluted EPS | $2.60 | $1.74 | | Adjusted non-GAAP Net Income | $175.7 million | $103.2 million | | Adjusted non-GAAP Diluted EPS | $3.32 | $1.97 | - CEO Dr. Jack Zhang emphasized strong momentum entering 2024, driven by the performance of glucagon, Primatene MIST®, and the acquisition of BAQSIMI®, which strengthens the diabetes portfolio[2](index=2&type=chunk) - A key milestone was the submission of the first Biologics License Application (BLA) for Insulin Aspart (AMP-004), highlighting continued pipeline development in diabetes management[2](index=2&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Fourth Quarter 2023 Financial Results](index=2&type=section&id=Fourth%20Quarter%20Results) Fourth quarter net revenues grew **32%** YoY to **$178.1 million**, primarily driven by a **70%** increase in Glucagon sales and **$22.5 million** in revenue from the newly acquired BAQSIMI®, with gross margin improving to **54%** from **53%** despite an inventory reserve charge, and operating expenses increasing due to BAQSIMI® sales and marketing efforts and higher R&D spending [Revenues](index=2&type=section&id=Q4%20Revenues) Q4 2023 Product Revenue Breakdown (in thousands) | Product | Q4 2023 Revenue | Q4 2022 Revenue | Change % | | :--- | :--- | :--- | :--- | | Glucagon | $31,198 | $18,319 | 70% | | Epinephrine | $24,646 | $21,427 | 15% | | Primatene MIST® | $24,484 | $22,279 | 10% | | Other revenues (BAQSIMI®) | $22,456 | $0 | N/A | | Enoxaparin | $6,092 | $7,812 | (22)% | | **Total Net Revenues** | **$178,105** | **$135,023** | **32%** | - Glucagon sales growth was driven by increased unit volumes after two competitors exited the market[4](index=4&type=chunk) - BAQSIMI® contributed **$22.5 million** in 'Other revenues', recognized on a net basis under a Transition Services Agreement with Eli Lilly. Amphastar expects to recognize the full revenue amount as it takes over distribution during 2024[4](index=4&type=chunk) [Gross Profit](index=2&type=section&id=Q4%20Gross%20Profit) - Gross profit increased **35%** to **$96.1 million**, with gross margin expanding to **54%** from **53%** in Q4 2022[5](index=5&type=chunk) - Margin improvement was driven by increased sales of higher-margin products like glucagon, Primatene MIST®, and newly launched regadenoson, plus the net revenue recognition of BAQSIMI®[5](index=5&type=chunk)[6](index=6&type=chunk) - Margin expansion was partially offset by a **$3.6 million** inventory reserve charge related to the amended Supply Agreement with MannKind Corporation[6](index=6&type=chunk) [Operating Expenses](index=3&type=section&id=Q4%20Operating%20Expenses) - Selling, distribution, and marketing expenses rose **58%** to **$8.6 million**, primarily due to the expansion of sales and marketing for BAQSIMI®[7](index=7&type=chunk) - Research and development expenses increased **18%** to **$20.4 million**, mainly due to higher material and supply costs for inhalation pipeline products[7](index=7&type=chunk) - Non-operating expenses were **$12.6 million**, a significant shift from an income of **$3.4 million** in Q4 2022, primarily due to interest expense on debt related to the BAQSIMI® acquisition[7](index=7&type=chunk) [Full-Year 2023 Financial Results](index=3&type=section&id=Year-End%20Results) Full-year 2023 net revenues increased **29%** to **$644.4 million**, propelled by a **105%** surge in Glucagon sales and **$51.2 million** from BAQSIMI®, with gross margin expanding significantly to **54%** from **50%** due to a richer product mix, while operating and non-operating expenses rose due to the BAQSIMI® acquisition and related financing costs [Revenues](index=3&type=section&id=FY23%20Revenues) Full-Year 2023 Product Revenue Breakdown (in thousands) | Product | FY 2023 Revenue | FY 2022 Revenue | Change % | | :--- | :--- | :--- | :--- | | Glucagon | $113,684 | $55,322 | 105% | | Primatene MIST® | $89,321 | $84,309 | 6% | | Epinephrine | $81,650 | $74,204 | 10% | | Other revenues (BAQSIMI®) | $51,157 | $0 | N/A | | Naloxone | $19,004 | $26,269 | (28)% | | **Total Net Revenues** | **$644,395** | **$498,987** | **29%** | - Glucagon sales more than doubled due to increased unit volumes following competitor product discontinuations[8](index=8&type=chunk) - BAQSIMI® contributed **$51.2 million** in 'Other revenues' for the year, based on Lilly's reported net sales of **$86.3 million**[9](index=9&type=chunk) - Naloxone sales declined **28%** due to lower unit volumes and a lower average selling price from increased competition[9](index=9&type=chunk) [Gross Profit](index=4&type=section&id=FY23%20Gross%20Profit) - Gross profit increased **41%** to **$351.1 million**, with gross margin expanding significantly to **54%** from **50%** in 2022[10](index=10&type=chunk) - The margin increase was driven by higher sales of high-margin products (Glucagon, Primatene MIST®), new product launches (ganirelix, vasopressin, regadenoson), and the net revenue recognition of BAQSIMI®[10](index=10&type=chunk) [Operating Expenses](index=4&type=section&id=FY23%20Operating%20Expenses) - Selling, distribution, and marketing expenses increased **34%** to **$28.9 million**, driven by BAQSIMI® marketing efforts and increased advertising for Primatene MIST®[11](index=11&type=chunk) - Research and development expenses remained relatively flat, decreasing **1%** to **$73.7 million**[11](index=11&type=chunk) - Non-operating expenses were **$25.6 million**, compared to an income of **$8.5 million** in 2022, primarily due to costs associated with the credit agreement to finance the BAQSIMI® acquisition[11](index=11&type=chunk) [Business and Pipeline Update](index=5&type=section&id=Business%20and%20Pipeline%20Update) [Cash Flow and Pipeline Information](index=5&type=section&id=Cash%20Flow%20and%20Pipeline%20Information) The company generated **$183.5 million** in cash flow from operating activities for the year ended December 31, 2023, maintaining a robust development pipeline with multiple ANDAs and biosimilar candidates on file with the FDA or in development, targeting markets worth several billion dollars - Cash flow provided by operating activities for the full year 2023 was **$183.5 million**[12](index=12&type=chunk) - The company has **four** ANDAs and **one** biosimilar insulin candidate currently on file with the FDA, targeting markets of over **$3 billion** and **$4 billion**, respectively[12](index=12&type=chunk) - There are an additional **three** biosimilar products and **six** generic products in development, targeting markets of over **$10 billion** and **$8 billion**, respectively[12](index=12&type=chunk) [Consolidated Financial Statements (Unaudited)](index=8&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) [Condensed Consolidated Statement of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) The statement details the company's revenues, costs, and profitability for the three and twelve months ended December 31, 2023, compared to the same periods in 2022, showing full-year net income increased to **$137.5 million** from **$91.4 million** in the prior year FY 2023 vs FY 2022 Statement of Operations (in thousands) | Line Item | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total net revenues | $644,395 | $498,987 | | Gross profit | $351,121 | $248,860 | | Income from operations | $196,987 | $107,497 | | Net income | $137,545 | $91,386 | | Diluted EPS | $2.60 | $1.74 | [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of December 31, 2023, shows a significant increase in total assets to **$1.51 billion** from **$742.0 million** at year-end 2022, primarily driven by the addition of goodwill and intangible assets from the BAQSIMI® acquisition, which also led to a substantial increase in total liabilities, particularly long-term debt Balance Sheet Highlights (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$1,512,912** | **$741,987** | | Cash and cash equivalents | $144,296 | $156,098 | | Goodwill and intangible assets, net | $613,295 | $37,298 | | **Total Liabilities** | **$873,491** | **$213,329** | | Long-term debt, net | $589,579 | $72,839 | | **Total Stockholders' Equity** | **$639,421** | **$528,658** | [Reconciliation of Non-GAAP Measures](index=10&type=section&id=Reconciliation%20of%20Non-GAAP%20Measures) This section provides a detailed reconciliation of GAAP net income to adjusted non-GAAP net income, showing that for the full year 2023, GAAP net income of **$137.5 million** was adjusted for items such as intangible amortization (**$12.8 million**), share-based compensation (**$20.2 million**), and BAQSIMI® acquisition-related expenses (**$5.8 million**) to arrive at a non-GAAP net income of **$175.7 million** FY 2023 GAAP to Non-GAAP Reconciliation (in thousands) | Description | Amount | | :--- | :--- | | **GAAP net income** | **$137,545** | | Intangible amortization | $12,830 | | Share-based compensation | $20,242 | | Impairment of long-lived assets | $3,175 | | Expenses related to BAQSIMI® acquisition | $5,830 | | Debt issuance costs | $6,785 | | Income tax provision on adjustments | ($10,708) | | **Non-GAAP net income** | **$175,699** | [Supplementary Information](index=5&type=section&id=Supplementary%20Information) [Non-GAAP Financial Measures](index=5&type=section&id=Non-GAAP%20Financial%20Measures) The company uses non-GAAP financial measures, such as Adjusted non-GAAP net income and Adjusted non-GAAP diluted EPS, to supplement its GAAP financial statements, excluding items like amortization, share-based compensation, impairment charges, and acquisition-related expenses to provide investors with a clearer view of ongoing operational performance - The company discloses non-GAAP measures because management uses them internally for forecasting, budgeting, and measuring operating performance[14](index=14&type=chunk) - Adjustments typically exclude amortization expense, share-based compensation, impairment charges, acquisition expenses, debt issuance costs, and legal settlements[14](index=14&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future financial performance, business trends, product development, and the prospective benefits of the BAQSIMI® acquisition, which are based on current expectations and subject to risks and uncertainties that could cause actual results to differ materially - Forward-looking statements cover expectations on future growth, sales, product development, FDA filings, and the impact of the BAQSIMI® acquisition[15](index=15&type=chunk)[16](index=16&type=chunk) - Investors are cautioned not to place undue reliance on these statements as they involve known and unknown risks, and the company undertakes no obligation to update them[16](index=16&type=chunk)
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